In Brief: Home Access Health
This article was originally published in The Tan Sheet
Home Access Health: FDA completes review of a premarket approval application for the firm's home-use HIV test system and has no serious concerns, Home Access says. The firm plans to forward a response to FDA in a matter of weeks to address minor issues raised by reviewers. Manufacturing site inspections also have been scheduled. The application, which has been under expedited review by the agency, was submitted at the end of May ("The Tan Sheet" June 5, p. 7). Home Access expects to bring the test system to market in the first half of 1996...
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